Prostatic HyperplasiaNCT02244320
Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)
An observational study of Prostatic Hyperplasia, run by Boehringer Ingelheim.
Trial summary
The objective of the observational study were to investigate the switch from phytotherapy to ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of ≥ 8 points (International Prostate Symptom Score (IPSS)) Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Tamsulosin
- How many people
- 4,150 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to May 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with functional BPH symptoms recruited at urologist offices
Who may be able to join
- Patients suffering from BPH symptoms
- Preceding treatment with a phytotherapeutic for at least 4 weeks
- IPSS sum score ≥ 8 points prior to treatment start with ALNA®
- Indication for a switch to treatment with ALNA® for a minimum period of 2 months
Who cannot join
- Patients fulfilling one of the general or specific contraindications listed in the ALNA® Summary of Product Characteristic, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency
- Patients receiving ALNA® within the 4 weeks prior to the start of the present observational study
About this study
Official title: Observational Study in Patients With Functional BPH (Benign Prostatic Hyperplasia) Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)
The objective of the observational study were to investigate the switch from phytotherapy to ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of ≥ 8 points (International Prostate Symptom Score (IPSS))
- Conditions
- Prostatic Hyperplasia
- Being tested
- Tamsulosin
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called ALNA®
| Study group | Role | What they receive |
|---|---|---|
| functional BPH | patients with functional BPH who switched from phytotherapy to ALNA® Receives: Drug: Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IPSS sum score
Measured: Day 1, 2 months
Change in Quality-of-Life Index (QoL) rated on a 7-point scale
Measured: Day 1, 2 months
Secondary outcomes (10)
Change in sexual satisfaction rated on a 4-point scale
Measured: Day 1, 2 months
Change in maximum urinary flow rate (ml/sec)
Measured: Day 1, 2 months
Change in residual urine volume (ml)
Measured: Day 1, 2 months
Patient's global assessment of the preceding phytotherapy on a 3-point scale
Measured: Day 1
Patient's global assessment of the therapy with ALNA® on a 3-point scale
Measured: after 2 months
Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale
Measured: Day 1
Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale
Measured: after 2 months
Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale
Measured: Day 1
Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale
Measured: after 2 months
Number of patients with adverse drug reactions (ADR)
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2002
- Primary completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244320
- Sponsor's protocol ID
- 527.38
- Status last verified
- Sep 2014
- First submitted
- 18 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study in Patients With Functional BPH (Benign Prostatic Hyperplasia) Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)
- ClinicalTrials.gov ID
- NCT02244320
- Acronym / sponsor ID
- 527.38
- Conditions
- Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,150 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- May 2003 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the observational study were to investigate the switch from phytotherapy to ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of ≥ 8 points (International Prostate Symptom Score (IPSS))
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| functional BPH | – | Drug: Tamsulosinpatients with functional BPH who switched from phytotherapy to ALNA® |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with functional BPH symptoms recruited at urologist offices
Key inclusion criteria (4 listed)
- Patients suffering from BPH symptoms
- Preceding treatment with a phytotherapeutic for at least 4 weeks
- IPSS sum score ≥ 8 points prior to treatment start with ALNA®
- Indication for a switch to treatment with ALNA® for a minimum period of 2 months
Key exclusion criteria (2 listed)
- Patients fulfilling one of the general or specific contraindications listed in the ALNA® Summary of Product Characteristic, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency
- Patients receiving ALNA® within the 4 weeks prior to the start of the present observational study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamsulosinAlso: ALNA® | Drug | functional BPH |
Primary outcome
Change in IPSS sum score
Time frame: Day 1, 2 months
Change in Quality-of-Life Index (QoL) rated on a 7-point scale
Time frame: Day 1, 2 months
10 secondary outcomes
Change in sexual satisfaction rated on a 4-point scale
Time frame: Day 1, 2 months
Change in maximum urinary flow rate (ml/sec)
Time frame: Day 1, 2 months
Change in residual urine volume (ml)
Time frame: Day 1, 2 months
Patient's global assessment of the preceding phytotherapy on a 3-point scale
Time frame: Day 1
Patient's global assessment of the therapy with ALNA® on a 3-point scale
Time frame: after 2 months
Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale
Time frame: Day 1
Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale
Time frame: after 2 months
Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale
Time frame: Day 1
Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale
Time frame: after 2 months
Number of patients with adverse drug reactions (ADR)
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Hyperplasia, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IPSS sum score (time frame: Day 1, 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014; AzTrials last refreshed its copy on 30 Oct 2026.